Autism Spectrum DisorderNCT06995274
Umbilical Cord Blood Therapy in a Child With Eosinophilic Duodenitis and Autism Spectrum Disorder: a Case Study
A study testing Umbilical Cord Blood Infusion (Autologous and Allogeneic) in people with Autism Spectrum Disorder and Eosinophilic Gastrointestinal Disorders, run by Bundang CHA Hospital.
Trial summary
This single-case exploratory clinical study aims to evaluate the therapeutic potential of umbilical cord blood (UCB) infusion in a pediatric patient diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 4 to 4 years, men only
- Conditions the study is for
- Autism Spectrum Disorder, Eosinophilic Gastrointestinal Disorders
- What is being tested?
- Umbilical Cord Blood Infusion (Autologous and Allogeneic)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 4 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Child aged 4 years at the time of enrollment
- Diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD)
- Actively receiving outpatient care at the Department of Rehabilitation Medicine, CHA Bundang Medical Center
- Autologous cord blood available and stored at an accredited cord blood bank
- Written informed consent provided by a legally authorized representative (parent or guardian) after receiving a full explanation of the study
Who cannot join
- Presence of a severe uncontrolled medical condition that may interfere with cord blood infusion or study assessments
- History of severe allergic reaction to components of the investigational product or immunosuppressive agents (e.g., cyclosporine)
- Current or recent participation (within 30 days) in another interventional clinical trial
- Any contraindication to MRI, EEG, or fNIRS assessments (e.g., implanted metal device, severe behavioral intolerance)
- Determined by the principal investigator to be unsuitable for participation due to safety concerns or noncompliance
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This single-case exploratory clinical study aims to evaluate the therapeutic potential of umbilical cord blood (UCB) infusion in a pediatric patient diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). ED is a rare inflammatory gastrointestinal condition characterized by excessive eosinophil infiltration in the duodenal mucosa, often associated with immune hypersensitivity and allergic responses. ASD is a neurodevelopmental disorder marked by deficits in social interaction, communication, and behavioral flexibility. Recent evidence suggests a link between gastrointestinal inflammation and neurodevelopmental symptoms via the gut-brain axis, especially in patients with co-occurring ASD and eosinophilic gastrointestinal disorders (EGIDs).
In this study, the patient will receive three UCB infusions: one autologous and two allogeneic. The first (autologous) UCB is stored at a certified cord blood bank and will be administered intravenously. Subsequently, two allogeneic UCB infusions will be administered six weeks apart using HLA-matched donor units selected from a hospital-based cord blood repository. The cell product will contain a minimum of 3 × 10⁷ total nucleated cells per kg, and donor-recipient compatibility for HLA A, B, and DRB1 will be considered.
Read more
To support immune tolerance and reduce potential adverse responses, a 7-day course of low-dose oral cyclosporine will be administered with each allogeneic infusion. All cord blood handling, thawing, and infusion will be performed in a cell therapy center under standardized protocols.
The primary aim is to explore the immune regulatory effects and symptom relief following UCB therapy in this rare comorbid case. Assessments will include brain MRI with DTI, EEG, fNIRS, sensory profiles (SP), social communication questionnaires (SCQ), autism rating scales (K-CARS-2), behavioral checklists (CBCL), gastrointestinal endoscopy, and developmental/cognitive/language assessments (e.g., WISC, WPPSI, GMFM, VMI, SELSI, PRES, FIM). Blood samples will be analyzed for eosinophil counts and gene/protein expression related to inflammation, neuroendocrine function, and gut-brain signaling (e.g., TNF-α, IL-6, serotonin, dopamine, GABA, CRH, BDNF).
This case study will also track safety indicators including vital signs, laboratory panels, and adverse events. The data may inform the feasibility of future therapeutic use of UCB in children with complex immune-neurodevelopmental conditions.
- Being tested
- Umbilical Cord Blood Infusion (Autologous and Allogeneic)
- Medical subject headings
- Autism Spectrum Disorder, Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood Infusion (Autologous and Allogeneic)Biological
The intervention consists of three intravenous infusions of umbilical cord blood (UCB) in a pediatric patient diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). The first infusion uses autologous UCB stored at a certified cord blood bank. The second and third infusions use allogeneic UCB units selected from a hospital-based donor cord blood bank. Donor units are matched at a minimum of 3 out of 6 HLA loci (HLA-A, B, DRB1) and contain ≥ 3×10⁷ total nucleated cells per kilogram of body weight.
Each infusion is administered intravenously via peripheral vein at the Cell Therapy Center of CHA Bundang Medical Center. Prior to each infusion, the participant receives premedication with intravenous chlorpheniramine maleate (0.6 mL/10 kg) to reduce the risk of allergic reactions. For allogeneic infusions, oral cyclosporine (0.07 mL/kg twice daily) is administered for 7 days (3 days before, day of, and 3 days after infusion) to minimize immune-mediated reactions
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord blood | Experimental | This is a single-arm, open-label, exploratory case study involving one pediatric participant diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). The intervention includes a series of three intravenous umbilical cord blood (UCB) infusions: one autologous UCB infusion followed by two allogeneic UCB infusions at 6-week intervals. Each infusion is performed under sterile conditions at a hospital-based cell therapy center. The donor UCB units are selected based on HLA compatibility (minimum 3/6 match for HLA-A, B, DRB1) and total nucleated cell count (≥ 3×10⁷ cells/kg). The allogeneic infusions are accompanied by a 7-day low-dose oral cyclosporine regimen to reduce the risk of immune rejection. The total study period includes baseline evaluation, three infusion sessions, and multiple post-infusion follow-up assessments over three months. Receives: Biological: Umbilical Cord Blood Infusion (Autologous and Allogeneic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Safety of Umbilical Cord Blood Infusion in a Child with Eosinophilic Duodenitis and Autism Spectrum Disorder
The number and severity of adverse events (AEs) and serious adverse events (SAEs) related to cord blood infusion will be assessed and categorized using MedDRA and CTCAE v5.0. Unit of measure is number of participants with AE or SAE
Measured: From baseline (within 6 months prior to first infusion) through 3 months after the final (third) UCB infusion (approximately 4-5 months total)
Secondary outcomes (9)
Change in Sensory Processing Scores (Sensory Profile)
To evaluate changes in sensory processing characteristics following umbilical cord blood (UCB) therapy using the Sensory Profile (SP), a standardized parent-report questionnaire assessing how sensory processing affects daily functioning. Improvement may indicate reduced sensory dysregulation, a common feature in ASD.
Measured: Baseline (within 6 months prior to first infusion), 7 days after each infusion, and 3 months after final infusion
Change in Social Communication (SCQ Score)
To assess changes in social communication behaviors and core ASD symptoms using the Social Communication Questionnaire (SCQ). These tools measure social reciprocity, communication, and autism symptom severity. Unit of Measure: Points (0-40)
Measured: Baseline, 7 days after each infusion, and 3 months after final infusion
Change in Behavioral Functioning (CBCL)
To monitor changes in behavioral and emotional functioning using the Child Behavior Checklist (CBCL), a standardized parent-report measure of internalizing and externalizing behaviors. Unit of Measure: Points
Measured: Baseline, 7 days after each infusion, and 3 months after final infusion
Change in Brain Connectivity and White Matter Integrity (MRI with DTI)
Measures white matter integrity via fractional anisotropy from DTI scans.Unit of Measure: FA value (unitless, 0-1 scale)
Measured: Baseline and 3 months after final infusion
Change in Cortical Hemodynamic Response (fNIRS)
To assess changes in prefrontal cortex activation during social and cognitive tasks using functional near-infrared spectroscopy (fNIRS), particularly during facial expression recognition and resting-state conditions. Unit of Measure: μmol/L
Measured: Baseline and 3 months after final infusion
Change in EEG Patterns
EEG analysis of relative power in frequency bands, pre-post UCB herapy, using AI (iSyncBrain).Unit of Measure: μV²/Hz
Measured: Baseline and 3 months after final infusion
Duodenal Eosinophil Count (if clinically indicated)
Duodenal Eosinophil Count (if clinically indicated) Unit of Measure: Eosinophils per high power field (HPF)
Measured: Baseline, 7 days after each infusion, and 3 months after final infusion
Change in Autism Severity (K-CARS-2)
To assess changes in core ASD symptoms using the Korean-Childhood Autism Rating Scale, 2nd Edition (K-CARS-2). These tools measure social reciprocity, communication, and autism symptom severity. Unit of Measure: Points (15-60)
Measured: Baseline, 7 days after each infusion, and 3 months after final infusion
Peripheral Blood Eosinophil Count
Change in Gastrointestinal Inflammation, Cells/μL
Measured: Baseline, 7 days after each infusion, and 3 months after final infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995274
- Sponsor's protocol ID
- 2025-03-057
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Blood Therapy in a Child With Eosinophilic Duodenitis and Autism Spectrum Disorder: a Case Study
- ClinicalTrials.gov ID
- NCT06995274
- Acronym / sponsor ID
- 2025-03-057
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-case exploratory clinical study aims to evaluate the therapeutic potential of umbilical cord blood (UCB) infusion in a pediatric patient diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). ED is a rare inflammatory gastrointestinal condition characterized by excessive eosinophil infiltration in the duodenal mucosa, often associated with immune hypersensitivity and allergic responses. ASD is a neurodevelopmental disorder marked by deficits in social interaction, communication, and behavioral flexibility. Recent evidence suggests a link between gastrointestinal inflammation and neurodevelopmental symptoms via the gut-brain axis, especially in patients with co-occurring ASD and eosinophilic gastrointestinal disorders (EGIDs).
In this study, the patient will receive three UCB infusions: one autologous and two allogeneic. The first (autologous) UCB is stored at a certified cord blood bank and will be administered intravenously. Subsequently, two allogeneic UCB infusions will be administered six weeks apart using HLA-matched donor units selected from a hospital-based cord blood repository. The cell product will contain a minimum of 3 × 10⁷ total nucleated cells per kg, and donor-recipient compatibility for HLA A, B, and DRB1 will be considered.
To support immune tolerance and reduce potential adverse responses, a 7-day course of low-dose oral cyclosporine will be administered with each allogeneic infusion. All cord blood handling, thawing, and infusion will be performed in a cell therapy center under standardized protocols.
The primary aim is to explore the immune regulatory effects and symptom relief following UCB therapy in this rare comorbid case. Assessments will include brain MRI with DTI, EEG, fNIRS, sensory profiles (SP), social communication questionnaires (SCQ), autism rating scales (K-CARS-2), behavioral checklists (CBCL), gastrointestinal endoscopy, and developmental/cognitive/language assessments (e.g., WISC, WPPSI, GMFM, VMI, SELSI, PRES, FIM). Blood samples will be analyzed for eosinophil counts and gene/protein expression related to inflammation, neuroendocrine function, and gut-brain signaling (e.g., TNF-α, IL-6, serotonin, dopamine, GABA, CRH, BDNF).
This case study will also track safety indicators including vital signs, laboratory panels, and adverse events. The data may inform the feasibility of future therapeutic use of UCB in children with complex immune-neurodevelopmental conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical cord blood | Experimental | Biological: Umbilical Cord Blood Infusion (Autologous and Allogeneic)This is a single-arm, open-label, exploratory case study involving one pediatric participant diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). The intervention includes a series of three intravenous umbilical cord blood (UCB) infusions: one autologous UCB infusion followed by two allogeneic UCB infusions at 6-week intervals. Each infusion is performed under sterile conditions at a hospital-based cell therapy center. The donor UCB units are selected based on HLA compatibility (minimum 3/6 match for HLA-A, B, DRB1) and total nucleated cell count (≥ 3×10⁷ cells/kg). The allogeneic infusions are accompanied by a 7-day low-dose oral cyclosporine regimen to reduce the risk of immune rejection. The total study period includes baseline evaluation, three infusion sessions, and multiple post-infusion follow-up assessments over three months. |
Who may qualify
- Ages
- 4 to 4 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child aged 4 years at the time of enrollment
- Diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD)
- Actively receiving outpatient care at the Department of Rehabilitation Medicine, CHA Bundang Medical Center
- Autologous cord blood available and stored at an accredited cord blood bank
- Written informed consent provided by a legally authorized representative (parent or guardian) after receiving a full explanation of the study
Key exclusion criteria (5 listed)
- Presence of a severe uncontrolled medical condition that may interfere with cord blood infusion or study assessments
- History of severe allergic reaction to components of the investigational product or immunosuppressive agents (e.g., cyclosporine)
- Current or recent participation (within 30 days) in another interventional clinical trial
- Any contraindication to MRI, EEG, or fNIRS assessments (e.g., implanted metal device, severe behavioral intolerance)
- Determined by the principal investigator to be unsuitable for participation due to safety concerns or noncompliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Blood Infusion (Autologous and Allogeneic)The intervention consists of three intravenous infusions of umbilical cord blood (UCB) in a pediatric patient diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). The first infusion uses autologous UCB stored at a certified cord blood bank. The second and third infusions use allogeneic UCB units selected from a hospital-based donor cord blood bank. Donor units are matched at a minimum of 3 out of 6 HLA loci (HLA-A, B, DRB1) and contain ≥ 3×10⁷ total nucleated cells per kilogram of body weight. Each infusion is administered intravenously via peripheral vein at the Cell Therapy Center of CHA Bundang Medical Center. Prior to each infusion, the participant receives premedication with intravenous chlorpheniramine maleate (0.6 mL/10 kg) to reduce the risk of allergic reactions. For allogeneic infusions, oral cyclosporine (0.07 mL/kg twice daily) is administered for 7 days (3 days before, day of, and 3 days after infusion) to minimize immune-mediated reactions | Biological | umbilical cord blood |
Primary outcome
Feasibility and Safety of Umbilical Cord Blood Infusion in a Child with Eosinophilic Duodenitis and Autism Spectrum Disorder
Time frame: From baseline (within 6 months prior to first infusion) through 3 months after the final (third) UCB infusion (approximately 4-5 months total)
The number and severity of adverse events (AEs) and serious adverse events (SAEs) related to cord blood infusion will be assessed and categorized using MedDRA and CTCAE v5.0. Unit of measure is number of participants with AE or SAE
9 secondary outcomes
Change in Sensory Processing Scores (Sensory Profile)
Time frame: Baseline (within 6 months prior to first infusion), 7 days after each infusion, and 3 months after final infusion
Change in Social Communication (SCQ Score)
Time frame: Baseline, 7 days after each infusion, and 3 months after final infusion
Change in Behavioral Functioning (CBCL)
Time frame: Baseline, 7 days after each infusion, and 3 months after final infusion
Change in Brain Connectivity and White Matter Integrity (MRI with DTI)
Time frame: Baseline and 3 months after final infusion
Change in Cortical Hemodynamic Response (fNIRS)
Time frame: Baseline and 3 months after final infusion
Change in EEG Patterns
Time frame: Baseline and 3 months after final infusion
Duodenal Eosinophil Count (if clinically indicated)
Time frame: Baseline, 7 days after each infusion, and 3 months after final infusion
Change in Autism Severity (K-CARS-2)
Time frame: Baseline, 7 days after each infusion, and 3 months after final infusion
Peripheral Blood Eosinophil Count
Time frame: Baseline, 7 days after each infusion, and 3 months after final infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Blood Infusion (Autologous and Allogeneic) in people with Autism Spectrum Disorder and Eosinophilic Gastrointestinal Disorders, run by Bundang CHA Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soyoung Choi (82 031 780 6003 ext. 6003, csy505@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Safety of Umbilical Cord Blood Infusion in a Child with Eosinophilic Duodenitis and Autism Spectrum Disorder (time frame: From baseline (within 6 months prior to first infusion) through 3 months after the final (third) UCB infusion (approximately 4-5 months total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.